Clean Room Analyst - Microbiological Environmental Monitoring
Location
Marlborough, MA | United States
Job description
Company Information
You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
Your Work Matters. At Cambrex, we strive to build a culture where all colleagues have the opportunity to:
- engage in work that matters to our customers and the patients they serve
- learn new skills and enjoy new experiences in an engaging and safe environment
- strengthen connections with coworkers and the community
We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more!
Your Future Matters. Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today!
Job Overview
Our Clean Room Services team is looking for both entry level and veteran Environmental Monitoring Analysts that are passionate about leveraging their talents to provide an outstanding customer experience. If you’re interested in receiving excellent training and working as part of a team of experts with opportunities for growth, you’ll be a great fit in our strong company culture.
As a Cleanroom Services Analyst you will perform environmental monitoring and cleanroom qualifications within controlled environments. You will travel to regional client sites to provide your expertise with equipment, procedures, policies and regulations to ensure that their cleanrooms meet the requirements for safe manufacturing of medical devices, pharmaceuticals and other patient products.
Responsibilities
- Expert use of scientific equipment while following policies and procedures
- Measure total air particulate, temperature, humidity and differential pressure
- Collect viable air and surface samples
- Collect purified water samples for testing
- Incubate media plates and enumerate any microbial growth
- Submit growth for microbial identification per procedure and client instruction
- Maintain and prepare equipment in a GMP environment.
- Prepare and complete documentation (paper and electronic) per GDP.
- Transport equipment and media to client sites within the New England region in company provided vehicles
- Familiarization with client cleanroom layouts, sampling plans and contamination control programs
- Sterile gowning and staging equipment and media into client cleanrooms for testing
- Other duties as assigned
- You will work with team members and under the direction of Cleanroom Services management to improve performance and client satisfaction.
Experienced Analysts will also - Perform compressed gas testing - Perform HEPA filter testing - Write risk assessments, sampling plans, investigations, protocols, reports, SOPs and other technical documents - Design and build electronic workflows - Peer review data - Assist with training - Cross-train to support other business functions, which may include: Validations, Metrology, Microbiology, Quality Assurance, Sales Support and Leadership
Qualifications/Skills
- Ability to read, analyze, interpret, and follow standard operating procedures, technical procedures, professional journals and governmental regulations to provide advantage to Cambrex opportunities.
- Mathematical skills including the ability to analyze scientific and test data, and a basic understanding of statistical analysis.
- Ability to effectively present information to internal and external audiences.
- Ability to write reports and business correspondences
- Actively participate in team and company meetings.
- Excellent interpersonal skills, with ability to interact effectively and work efficiently with customers, partners and colleagues at all levels in an organization.
- Excellent communication skills: verbal, written and active listening.
Education, Experience & Licensing Requirements
- Maintains a valid driver’s license and has a good driving record.
Entry Level Qualifications - Associate’s degree in Microbiology or related field with a minimum of 12 months of working in a clean room environment -OR- High School Diploma or equivalent will be considered with a minimum of 24 months of working in a clean room environment
- Sterile gowning experience preferred
Expert Level Qualifications - Bachelor’s degree or higher in Microbiology or related field
- Minimum of 12 months of sterile gowning experience
- Minimum of 12 months of environmental monitoring sampling and testing experience
- CETA or NEBB training / certification preferred
All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities.
Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
#LI-SK1
Travel: Significant part of role. Will travel to client sites and may perform work at client sites. Physical Demands:
The physical demands described here are representative of those that must be met by an employee
to successfully perform the essential functions of this job. Reasonable accommodations may be
made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee may be required to use hands to finger,
handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The
employee is frequently required to stand, walk and sit. The employee may be occasionally required
to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds,
frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds.
Specific vision abilities required by this job include close vision, distance vision, and peripheral
vision.
Environment and Protective Equipment:
The work environment characteristics described here are representative of those an employee
encounters while performing the essential functions of this job. Reasonable accommodations may
be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee may be occasionally exposed to moving
mechanical parts, high precarious places and vibration. The noise level in the work environment is
usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas
for inspections or work discussions. The employee is required to wear the appropriate personal
protective equipment to perform the job duties. Such personal protective equipment may include
but is not limited to: safety eyewear, various types of respirators/breathing apparatus, lab coats,
gloves, etc.
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